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The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.

• Carpal tunnel release for carpal tunnel syndrome .
• Plantar fasciotomy for plantar fasciitis .
• Lateral release of the knee for extensor mechanism malalignment .
• Forearm fasciotomy for compartment syndrome
• . Morton's neuroma for interdigital neuroma
• Gastrocnemius release for heel cord contracture (equinus) .

The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.

The provided text describes a 510(k) summary for the A.M. Surgical Mountable Endoscopic Blade. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/software device.

Here's an analysis based on the provided text for a manual surgical instrument, not an AI or software device:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
For this type of device (a manual surgical instrument), the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for algorithms. Instead, acceptance is based on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. This equivalence is established by comparing intended use, material composition, and design features, and then asserting that this similarity ensures comparable safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) relies on substantial equivalence to a predicate device (K982142), not on a new clinical study with a specific test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No "ground truth" for a test set was established in the context of a new clinical study for this device.

4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. This is a 510(k) for a manual surgical instrument, not an AI/software device that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used
Not applicable. The basis for clearance is substantial equivalence to a predicate device, not empirical ground truth data from a new study.

8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires training data.

9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device.

Summary of the Study and Conclusion:

The "study" or justification for the A.M. Surgical Mountable Endoscopic Blade is a Substantial Equivalence (SE) determination under the 510(k) pathway.

• Acceptance Criteria Met: The device met the regulatory acceptance criteria by demonstrating substantial equivalence to a previously cleared predicate device, the Mountable Endoscopic Blade (K982142). This means its intended use, material composition (stainless steel), and design features (mounts to a 4mm 30° endoscope) were found to be sufficiently similar to the predicate to ensure equivalent safety and effectiveness.
• Proof: The entire 510(k) submission, specifically section D ("Substantial Equivalence Information"), serves as the "study" or proof. It asserts that "The safety and effectiveness of Mountable Endoscopic Blade is adequately supported by the substantial equivalence information provided within this Premarket Notification." The FDA's letter concurs with this finding, stating that the device is "substantially equivalent."

In essence, for this medical device, the "study" is a regulatory comparison rather than a clinical trial or performance evaluation against specific numerical targets.

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